Infertility/Sterility Clinical Trial
Official title:
Positive Adjustment in Case of Involuntary Childlessness - a Smartphone-supported Intervention Study as RCT
Involuntary childlessness is experienced as emotionally stressful, however psychosocial counseling is not always available on the spot. Aim of this RCT study is to examine the efficacy and acceptance of a psychological low-dose online intervention for couples in reproductive treatment.
About 8% of all couples of reproductive age are involuntary childless, and just about 25,000
couples receive a medical treatment each year in Germany, which is experienced as "roller
coaster of emotions". The positive effect of "face-to-face" counseling for couples with a
desire for children has been proven. However, this does not yet apply to a variety of other
forms of intervention, e.g. telephone or online counseling.
In this study, the effectiveness of a smartphone-supported psychosocial intervention for
women and men in reproductive treatment will be examined in a randomized controlled pre-post
design.
For this purpose, an intervention group and a comparison intervention group of each n = 60
couples in reproductive treatment will be examined at two points during a four-week interval
using the ScreenIVF questionaire. The ScreenIVF will be completed paper-pencil before the
intervention and online after the intervention. In the fourteen-day waiting period between
oocyte puncture and pregnancy test (or the reappearance of menstruation), both groups receive
either positive adjustment techniques or brainteasers.In addition, both groups are questioned
one month after the post-measurement date on the perceived effectiveness and practicability
of the intervention techniques.
Sociodemographic variables (such as age, education) and medical data (such as diagnosis,
previous treatment cycles) as potential moderators, as well as possible pregnancies at the
second measurement time will be reported.
No adverse effects or other risks are expected for the study participants.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03348865 -
Fertility Life Counselling Aid- FeLiCiA
|
N/A | |
| Recruiting |
NCT03477929 -
Cetrorelix and Ganirelix Flexible Protocol for (IVF)
|
Phase 4 | |
| Enrolling by invitation |
NCT03350009 -
Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality
|